VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus Penicillin (<=0.06 - >=8 µg/mL), VITEK 2 Streptococcus Penicillin
FDA 510(k) K232201 · bioMerieux, Inc.
510(k) numberK232201
Submission
- Device name
- VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus Penicillin (<=0.06 - >=8 µg/mL), VITEK 2 Streptococcus Penicillin
- Applicant
- bioMerieux, Inc.
Hazelwood, MO, US - Received
- July 25, 2023
- Decision date
- October 23, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LON – System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.1645
- Specialty
- Microbiology
Other 510(k)s with product code LON
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260282 | VITEK 2 AST-Streptococcus Inducible Clindamycin ResistanceLON · Traditional | bioMerieux, Inc. | 04/15/2026SE |
| K260281 | VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)LON · Traditional | Biomerieux | 03/26/2026SE |
| K251579 | VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)LON · Traditional | bioMerieux, Inc. | 08/21/2025SE |
| K251713 | BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL)LON · Traditional | Becton, Dickinson and Company | 08/08/2025SE |
| K250447 | BD Phoenix Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL)LON · Traditional | Becton, Dickinson and Company | 05/19/2025SE |
| K234012 | Vitek Compact ProLON · Traditional | bioMerieux, Inc. | 03/14/2025SE |
| K250344 | BD Phoenix Automated Microbiology SystemLON · Special | Becton, Dickinson and Company | 03/06/2025SE |
| K233986 | BD Phoenix Automated Microbiology System - GN Ciprofloxacin (0.01564 µg/mL)LON · Traditional | Becton, Dickinson and Company | 03/15/2024SE |
| K234000 | VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL)LON · Traditional | bioMerieux, Inc. | 03/11/2024SE |
| K232756 | ColibríLON · Traditional | Copan Wasp Srl | 12/27/2023SE |
More from Copan Wasp Srl
| 510(k) | Device | Decision |
|---|---|---|
| K260160 | VITEK REVEAL GN AST Assay and VITEK REVEAL AST SystemSAN · Traditional | 07/08/2026SE |
| K260282 | VITEK 2 AST-Streptococcus Inducible Clindamycin ResistanceLON · Traditional | 04/15/2026SE |
| K260281 | VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)LON · Traditional | 03/26/2026SE |
| K251579 | VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)LON · Traditional | 08/21/2025SE |
| K234012 | Vitek Compact ProLON · Traditional | 03/14/2025SE |
| K232967 | VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL)NGZ · Traditional | 06/12/2024SE |
| K232963 | VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL)NGZ · Traditional | 06/07/2024SE |
| K240279 | Vidas Tbi (Gfap, UCH-L1)QAT · Traditional | 05/01/2024SE |
| K234000 | VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL)LON · Traditional | 03/11/2024SE |
| K230864 | VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin…LON · Traditional | 07/05/2023SE |
Questions and answers
When was VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus Penicillin (<=0.06 - >=8 µg/mL), VITEK 2 Streptococcus Penicillin cleared by the FDA?
VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus Penicillin (<=0.06 - >=8 µg/mL), VITEK 2 Streptococcus Penicillin (K232201) received a 510(k) decision of Substantially Equivalent on October 23, 2023, 90 days after the submission was received.
What is the product code of K232201?
The FDA product code is LON – System, Test, Automated, Antimicrobial Susceptibility, Short Incubation, a Class II (moderate risk) device regulated under 21 CFR 866.1645.